Device evaluation: eCoin #x2013; implantable tibial nerve stimulator for overactive bladder.

IF 2.9 3区 医学 Q3 ENGINEERING, BIOMEDICAL
Expert Review of Medical Devices Pub Date : 2023-07-01 Epub Date: 2023-09-10 DOI:10.1080/17434440.2023.2254678
Morgan J Bressington, David Scholtz, Ali Hooshiary, Wikus Vermeulen, Timothy Burns, Flavio Ordones, Peter Gilling
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引用次数: 0

Abstract

Introduction: Peripheral nerve stimulation has been demonstrated as a viable alternative to sacral nerve stimulation in managing refractory overactive bladder (OAB). New technologies allow the internalization of tibial nerve stimulators through various apparatuses. One such device, the eCoin, is a small, coin-shaped device that can be implanted adjacent to the tibial nerve that provides pre-programmed stimulation.

Areas covered: We will review the literature on eCoin implantation, from proof of concept to mid-term data, with the longest period of follow-up being 12 months. All studies on this technology will be reviewed, along with an analysis of the current state of play in implantable neuromodulators for overactive bladder. Efficacy, durability, adverse events, and viability of eCoin as a long-term management option will be considered.

Expert opinion: The eCoin device demonstrates promising early data for efficacy in managing overactive bladder symptoms. Complication rates remain low and are mostly related to wound healing following the initial placement of the device. Research into the continued improvement and modification of the device appears optimistic, but longer-term data still need to be obtained. Indeed, implantable PTNS have a role in the future management of overactive bladder, and devices such as eCoin will still need to prove a long-term benefit to be a mainstay of management.

器械评估:eCoin-可植入胫骨神经刺激器治疗膀胱过度活动。
引言:外周神经刺激已被证明是治疗难治性膀胱过度活动症(OAB)的骶神经刺激的可行替代方案。新技术允许通过各种装置将胫骨神经刺激器内部化。一种这样的设备,eCoin,是一种小型的硬币状设备,可以植入胫骨神经附近,提供预先编程的刺激。涵盖领域:我们将回顾关于eCoin植入的文献,从概念验证到中期数据,最长随访期为12 月。将对这项技术的所有研究进行综述,并对可植入神经调节剂治疗膀胱过度活动症的现状进行分析。将考虑eCoin作为长期管理选择的疗效、耐用性、不良事件和生存能力。专家意见:eCoin设备证明了治疗膀胱过度活动症状的早期疗效数据。并发症发生率仍然很低,主要与初次放置器械后的伤口愈合有关。对该设备的持续改进和改进的研究似乎很乐观,但仍需获得长期数据。事实上,植入式PTNS在膀胱过度活动的未来管理中发挥着作用,像eCoin这样的设备仍需要证明其长期益处,才能成为管理的支柱。
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来源期刊
Expert Review of Medical Devices
Expert Review of Medical Devices 医学-工程:生物医学
CiteScore
5.90
自引率
3.20%
发文量
69
审稿时长
6-12 weeks
期刊介绍: The journal serves the device research community by providing a comprehensive body of high-quality information from leading experts, all subject to rigorous peer review. The Expert Review format is specially structured to optimize the value of the information to reader. Comprehensive coverage by each author in a key area of research or clinical practice is augmented by the following sections: Expert commentary - a personal view on the most effective or promising strategies Five-year view - a clear perspective of future prospects within a realistic timescale Key issues - an executive summary cutting to the author''s most critical points In addition to the Review program, each issue also features Medical Device Profiles - objective assessments of specific devices in development or clinical use to help inform clinical practice. There are also Perspectives - overviews highlighting areas of current debate and controversy, together with reports from the conference scene and invited Editorials.
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